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Status unknownNCT01936233Updated Aug 5, 2019

Clinical Study of Antiviral and Aspirin Treatment in Liver Cancer After Radical Surgery

A Phase 3 interventional study of Aspirin and Lamivudine in Hepatocellular Carcinoma and Recurrence, sponsored by Fudan University. Status unknown at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2019-08-05.

Sponsored by Fudan University · Phase 3, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Dec 2018), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 3
Study type
Interventional
Enrollment
112
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

Evaluation the Treatment Outcome of Antiviral and Aspirin Treatment in Liver Cancer After Radical Surgery.

Read the detailed description

The investigators conduct this clinical trial to evaluate the treatment outcome of Antiviral and Aspirin Treatment in Liver Cancer After Radical Surgery.The primary outcome is overall survival and objective response rate.

02

Conditions studied

  • Hepatocellular Carcinoma
  • Recurrence

Keywords

  • Hepatocellular Carcinoma
  • Aspirin
  • antiviral treatment
  • recurrence free survival
  • radical therapy
03

In context

Carcinoma, Hepatocellular

3,249 studies on the registry are indexed under Carcinoma, Hepatocellular; 974 are open to participants now.

This study's planned enrollment of 112 is above the median of 55 across 2,347 interventional studies indexed under Carcinoma, Hepatocellular.

Browse Carcinoma, Hepatocellular studies →

Lead sponsor

Fudan University is the lead sponsor of 1,308 studies on the registry; 637 are open to participants now.

Browse Fudan University studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Hepatocellular carcinoma confirmed with pathology or identified with radiological images with typical features
  • Age ≥ 18 years and ≤ 75 years
  • At least one tumor nodule with one uni-dimension of ≥ 2 cm
  • Child-Pugh Class A or B
  • HBV-DNA>10\^4
  • Total bilirubin ≤ 1.5 x upper limit of normal
  • ALT and AST ≤ 2.0 x the upper limit of normal
  • PT-INR\<2.3,PTT \< 1.5 x upper limit of normal
  • Serum creatinine ≤ 1.5x upper limit of normal
  • Peripheral white blood cell count of or more than 3×10(9)/L
  • Peripheral platelet of or more than 50×10(9)/L
  • Expected survival time not less than 3 months
  • ECOG score 0-2

Exclusion criteria

Exclusion Criteria:

  • Tumor thrombi in main branch of portal vein
  • Tumor involvement more than 70% of whole liver
  • With extrahepatic metastasis
  • Prior systemic chemotherapy or chemoembolization
  • Congestive heart failure > NYHA class 2
  • History of HIV infection
  • Active clinically serious infections (> 2 NCI-CTC Version 3.0)
  • Recurrence of HCC after liver transplantation
  • Pregnant or breast-feeding
  • Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in this study
  • Known or suspected allergy to any agent given in association with this trial
  • Patients unable to swallow oral medication
  • Inclined to thrombosis
  • Inclined to hemorrhage or active hemorrhage with 1 month
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
112 participants (estimated)

Study arms

  • Experimental
    Aspirin AND Lamivudine

    Drug: Aspirin · Drug: Lamivudine

  • Active comparator
    Lamivudine

    Drug: Lamivudine

Interventions

06

What researchers measure

Primary outcomes

  1. recurrence free survival

    Time frame: 36 months

Secondary outcomes

  1. overall survival

    Time frame: 36 months

  2. adverse events

    Time frame: 36 months

07

Study locations

1 of 1 sites recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 5, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01936233
Lead sponsor
Fudan University
Responsible party
Zheng-Gang Ren (chief of departement, Fudan University) — Principal investigator
First posted
Sep 6, 2013
Start date
Aug 2013
Primary completion
Dec 2021 (estimated)
Completion
Dec 2023 (estimated)
Last update
Aug 5, 2019

Study contacts

Zheng-Gang Ren, Ph.D
Contact
ren.zhenggang@zs-hospital.sh.cn
0086-021-64041990 ext. 2149
Lan Zhang, Ph.D
Contact
zhang.lan@zs-hospital.sh.cn
0086-021-64041990 ext. 2971
Zhenggang Ren, Ph.D
principal investigator · Fudan University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2018. You cannot join it, but the record below documents what was studied.

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